A Study to Find a Suitable Dose of BI 1821736 and Test Whether it Helps People With Advanced Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-07

Study Completion Date

2025-04-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is open to adults with advanced solid tumours. People with solid tumours for whom previous treatment was not successful or no treatment exists can take part.

The purpose of this study is to find the highest dose of a medicine called BI 1821736 that people with advanced solid tumours can tolerate. BI 1821736 is a type of immunotherapy. It is a special virus that kills cancer cells and helps the immune system fight cancer. In this study, BI 1821736 is given to humans for the first time.

Participants receive BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months. Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by BI 1821736.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Test Different Doses of BI 1831169 Alone and in Combination With an Anti-PD-1 Antibody in People With Different Types of Advanced Cancer (Solid Tumors)

NCT05155332

Solid Tumors

RECRUITING PHASE1

A Study to Test How Different Doses of BI 1703880 in Combination With Ezabenlimab Are Tolerated in People With Different Types of Advanced Cancer (Solid Tumours)

NCT05471856

Solid Tumors

RECRUITING PHASE1

Weekly BI 836880 in Patients With Advanced Solid Tumors

NCT02689505

Neoplasms

COMPLETED PHASE1

A Study in People With Advanced Cancer to Test How Well Different Doses of BI 770371 Alone or in Combination With Ezabenlimab Are Tolerated

NCT05327946

Solid Tumors

ACTIVE_NOT_RECRUITING PHASE1

BI 2536 BS in Patients With Advanced Solid Tumours and Repeated Administration in Patients With Clinical Benefit

NCT02211872

Neoplasms

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Solid Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BI 1821736: Dose escalation cohort

Group Type EXPERIMENTAL

BI 1821736

Intervention Type DRUG

Solution for infusion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BI 1821736

Solution for infusion

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histologically confirmed diagnosis of malignant tumor.
* Advanced, unresectable and/or metastatic or relapsed/refractory solid tumors.
* Has failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Patient must have exhausted available treatment options known to prolong survival for their disease.
* Has at least one tumoral lesion which is amenable to biopsy.
* Signed and dated, written informed consent form (ICF) in accordance with ICH-GCP and local legislation obtained prior to any trial-specific procedures, sampling, or analyses that are not part of normal standard of practice care.
* Eastern Cooperative Oncology Group score of 0 or 1.
* Adequate organ function or bone marrow reserve defined as demonstrated at screening by the following laboratory values:

* Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (≥ 1.5 x 10\^3/μL)(≥ 1500/mm\^3); haemoglobin ≥ 90 g/L (≥ 9.0 g/dL)(≥ 5.6 mmol/L); platelets ≥ 100 x 10\^9/L (≥ 100 x 10\^3/μL)(≥ 100 x 10\^3/mm\^3) without the use of haematopoietic growth factors within 4 weeks of start of trial medication.
* Creatinine ≤ 1.5 times the upper limit of normal (ULN).
* Total bilirubin ≤ 1.5 times the ULN, except for patients with Gilbert's syndrome: total bilirubin ≤ 3 times ULN or direct bilirubin ≤ 1.5 times ULN.
* Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 times ULN if no demonstrable liver metastases, or otherwise ≤ 5 x ULN if transaminase elevation is attributable to liver metastases.
* Partial thromboplastin (PT) / activated partial thromboplastin time (aPTT) \<1.5 times ULN unless on a stable dose of an anticoagulant.
* All toxicities related to previous anti-cancer therapies have resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 prior to trial treatment administration (except for alopecia and peripheral neuropathy which must be ≤ CTCAE Grade 2 and amenorrhea/menstrual disorders which can be any grade).

Exclusion Criteria

* Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to start of study treatment.
* Previous treatment with Vesicular Stomatitis Virus (VSV)-based agents.
* Patients with brain metastases unless they have completed brain radiotherapy and are asymptomatic.
* Radiotherapy within 4 weeks prior to the start of study treatment, except in case of a brief course of palliative radiotherapy (e.g. for analgesic purpose or for lytic lesions at risk of fracture) which can then be completed within two weeks prior to start of study treatment.

Note: No radiation must have been given to any lesions planned to be biopsied within 6 months of start of treatment.

* Prior (within 3 weeks of first dose) or concomitant use of systemic corticosteroids (\>10 mg daily prednisone or equivalent).
* Prior (within 3 weeks of first dose or less than 5 half-lives) or concomitant use of a medication or a condition considered a high risk for complications from biopsy as per the Investigator's judgement.
* Prior (within 3 weeks of first dose or less than 5 half-lives) or concomitant use of interferon, immunotherapy agents, or tamoxifen.
* Active infection requiring systemic therapy (antibacterial, antiviral, antiparasitic or antifungal therapy) at the start of treatment in the trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No